Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer (PHC-BC)
HER2-positive Breast Cancer
About this trial
This is an interventional diagnostic trial for HER2-positive Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
- Primary tumor greater than (>) 2 cm in diameter.
- Age ≥ 18 years and < 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1.
- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55%
- Availability of tumor tissue specimen after surgery.
- Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
- Histologically proven diagnosis of breast cancer.
- Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
- Had hormonal receptors (ER and PgR) assessed.
- Signed informed consent.
- Able to comply with the protocol.
Exclusion Criteria:
- Metastatic disease (Stage IV) or bilateral breast cancer.
- Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer.
- Prior breast or non-breast malignancy within 5 years prior to study entry.
- Inadequate bone marrow, renal, or liver function
- History or evidence of cardiovascular condition
- Severe, uncontrolled systemic disease
- Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications.
- Pregnancy or breast-feeding women.
- Participants who received any investigational treatment within 4 weeks of study start.
- Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
- Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids]).
- Known hypersensitivity to any of the study drugs or excipients
Sites / Locations
- Shanghai Cancer Center, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Experimental
TCHP
Neoadjuvant Therapy (Cycles 1-7): Cycle 1: Pertuzumab (840mg loading dose, 420mg maintenance dose) + Trastuzumab (8mg/kg loading dose, 6-mg/kg maintenance dose) Cycle 2-7: Pertuzumab (840mg loading dose, 420mg maintenance dose) + Trastuzumab (8mg/kg loading dose, 6-mg/kg maintenance dose) + followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m2 then to 60mg/m2 (q3w). Adjuvant Therapy:patients would complete 1 year of PH-based regimen in the adjuvant setting. Patients are assessed by [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and 68Ga-Affibody HER-2 Imaging PET. Besides, the changes of biomarkers would be examined by gene sequencing and organoid drug sensitivity test.